Back to resultsHypoglycemic Effects of a Dietary Supplement With Inositols, Gymnema Silvestre, Alpha-lactalbumin and Zinc. (EUDIA_22)
Primary Purpose
Metabolism Disorder
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
EUDIAMET
Sponsored by
About this trial
This is an interventional supportive care trial for Metabolism Disorder
Eligibility Criteria
Inclusion Criteria:
- BMI between 30 and 35
- Basal Glycemia between 100 and 125 mg/dl
Exclusion Criteria:
- Diabetes diagnosis
- Use of food supplements containing inositols, gymnema, alpha-lactalbumin and zinc
- Intolerance to inositols, gymnema, alpha-lactalbumin and zinc
Sites / Locations
- Sapienza University of Rome
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
EUDIAMET
Arm Description
Hypocaloric diet
Hypocaloric diet plus a supplementation with myo-inositol and D-chiro-inositol in the 40:1 ratio, Gymnema sylvestre, alpha-lactalbumin and zinc
Outcomes
Primary Outcome Measures
Insulinemia
Reduction of systemic insulin levels
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05348304
Brief Title
Hypoglycemic Effects of a Dietary Supplement With Inositols, Gymnema Silvestre, Alpha-lactalbumin and Zinc.
Acronym
EUDIA_22
Official Title
Hypoglycemic Effects of a Dietary Supplement That Combines the Properties of Myo-inositol and D-chiro-inositol With Gymnema Silvestre, Alpha-lactalbumin and Zinc.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
June 28, 2022 (Actual)
Primary Completion Date
September 26, 2022 (Actual)
Study Completion Date
October 12, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lo.Li.Pharma s.r.l
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study is aimed at evaluating the hypoglycemic effects of a dietary supplement that associates the properties of two inositols (myo-inositol and D-chiro-inositol) in the ratio 40:1 to Gymnema sylvestre, alpha-lactalbumin and zinc.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolism Disorder
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Hypocaloric diet
Arm Title
EUDIAMET
Arm Type
Experimental
Arm Description
Hypocaloric diet plus a supplementation with myo-inositol and D-chiro-inositol in the 40:1 ratio, Gymnema sylvestre, alpha-lactalbumin and zinc
Intervention Type
Dietary Supplement
Intervention Name(s)
EUDIAMET
Intervention Description
A combination of myo-inositol and D-chiro-inositol in the 40:1 ratio, Gymnema sylvestre, alpha-lactalbumin and zinc
Primary Outcome Measure Information:
Title
Insulinemia
Description
Reduction of systemic insulin levels
Time Frame
Three time points: change in insulin levels from the baseline to three and six months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
BMI between 30 and 35
Basal Glycemia between 100 and 125 mg/dl
Exclusion Criteria:
Diabetes diagnosis
Use of food supplements containing inositols, gymnema, alpha-lactalbumin and zinc
Intolerance to inositols, gymnema, alpha-lactalbumin and zinc
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabrina Basciani
Organizational Affiliation
University of Roma La Sapienza
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sapienza University of Rome
City
Rome
State/Province
RM
ZIP/Postal Code
00161
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Hypoglycemic Effects of a Dietary Supplement With Inositols, Gymnema Silvestre, Alpha-lactalbumin and Zinc.
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